Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis
NCT00414128 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2013-12-06
Summary
The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.
Conditions
- Vasculitis
Interventions
- DRUG
-
mycophenolate mofetil
2-3g/day for 3-6 months, in tablet, capsule or liquid form
- DRUG
-
intravenous cyclophosphamide, 15mg/kg with dose reductions according to age and renal function, for 3-6 months (6-10 doses total)
Sponsors & Collaborators
-
Aspreva Pharmaceuticals
collaborator INDUSTRY -
Vifor Pharma
collaborator INDUSTRY -
Cambridge University Hospitals NHS Foundation Trust
lead OTHER
Principal Investigators
-
David Jayne · Addenbrooke's Hospital, Cambridge, UK
-
Lorraine Harper · Birmingham University, UK
-
Rachel Jones · Addenbrooke's Hospital, UK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2011-07-31
- Completion
- 2013-02-28
Countries
- United Kingdom
Study Locations
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